EP1987858A2 - Système de support de suivi pour dispositifs médicaux implantables - Google Patents

Système de support de suivi pour dispositifs médicaux implantables Download PDF

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Publication number
EP1987858A2
EP1987858A2 EP08075255A EP08075255A EP1987858A2 EP 1987858 A2 EP1987858 A2 EP 1987858A2 EP 08075255 A EP08075255 A EP 08075255A EP 08075255 A EP08075255 A EP 08075255A EP 1987858 A2 EP1987858 A2 EP 1987858A2
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EP
European Patent Office
Prior art keywords
imd
irregularity
follow
index
support unit
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP08075255A
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German (de)
English (en)
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EP1987858A3 (fr
EP1987858B1 (fr
Inventor
Volker Kukla
Joachim Reinke
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biotronik CRM Patent AG
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Biotronik CRM Patent AG
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Publication date
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Publication of EP1987858A2 publication Critical patent/EP1987858A2/fr
Publication of EP1987858A3 publication Critical patent/EP1987858A3/fr
Application granted granted Critical
Publication of EP1987858B1 publication Critical patent/EP1987858B1/fr
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/37Monitoring; Protecting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/3621Heart stimulators for treating or preventing abnormally high heart rate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37235Aspects of the external programmer
    • A61N1/37247User interfaces, e.g. input or presentation means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37252Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37264Changing the program; Upgrading firmware
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators
    • A61N1/3925Monitoring; Protecting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators
    • A61N1/3956Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
    • A61N1/3962Implantable devices for applying electric shocks to the heart, e.g. for cardioversion in combination with another heart therapy
    • A61N1/39622Pacing therapy
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/40ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/0266Operational features for monitoring or limiting apparatus function
    • A61B2560/0271Operational features for monitoring or limiting apparatus function using a remote monitoring unit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/37Monitoring; Protecting
    • A61N1/3702Physiological parameters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/37Monitoring; Protecting
    • A61N1/371Capture, i.e. successful stimulation

Definitions

  • the invention refers to an integrated bi-directional data communication and follow-up system for at least one implanted medical device (IMD).
  • IMD implanted medical device
  • the invention relates in particular to follow up systems for an implantable cardiac pacemaker an implantable pulse generator (IPG) or an implantable cardioverter/defibrillator (ICD).
  • IPG implantable pulse generator
  • ICD implantable cardioverter/defibrillator
  • Implantable heart stimulators can be used for treating a variety of heart disorders like bradycardia, tachycardia or fibrillation by way of electric stimulation pulses delivered to the heart tissue, the myocardium. Strong enough a stimulation pulse outside a heart chamber's refractory period leads excitation of the myocardium of that heart chamber, which in turn is followed by a contraction of the respective heart chamber.
  • such heart stimulator Depending on the disorder to be treated, such heart stimulator generates electrical stimulation pulses that are delivered to the heart tissue (myocardium) of a respective heart chamber according to an adequate timing regime. Delivery of stimulation pulses to the myocardium is usually achieved by means of an electrode lead that is electrically connected to a stimulation pulse generator inside a heart stimulator's housing and that carries a stimulation electrode in the region of its distal end. A stimulation pulse also is called a pace. Similarly, pacing a heart chamber means stimulating a heart chamber by delivery of a stimulation pulse.
  • Parameters defining a therapy to be delivered by a heart stimulator need to be adapted to a patient's need. After adapting all parameters there may occur nevertheless irregularities such as unsuccessful attempts of treating a tachycardia by means of an antitachycardia therapy (antitachycardia pacing; ATP). This may necessitate reprogramming the antitachycardia therapy during a next follow up session.
  • an antitachycardia therapy antitachycardia therapy
  • IMDs may feature a telemetry unit for wireless access to the implanted medical device.
  • IMDs such as pacemakers offer a plurality of operation modes and feature a number of adjustable parameters to best match the IMDs configuration to a patient's individual need.
  • state of the art pacemakers collect a number of operational and physiological data such as, inter alia, data representing an intracardiac electogram.
  • Operational data collected and stored by the IMD include irregularity indicators indicating irregularities such as incidents of tachycardia etc. These indicators are at least temporarily stored in an IMDs memory.
  • a patient having an IMD meets a physician that checks the patient's health state and the state of the IMD.
  • a physician that checks the patient's health state and the state of the IMD.
  • the physician is able to read out the IMD's memory and to reprogram the IMD if necessary.
  • Irregularities felt by the patient are noted by the physician during follow-up and may entice the physician to adapt the operational parameters of the IMD.
  • the IMD may wirelessly communicate data to an external device in the patient' proximity.
  • the external device can be linked to a remote service center for collection of data collected or generated by the IMD.
  • Such a system is, for example, disclosed in US 2003/0028082 .
  • IMD implanted medical device
  • an IMD follow-up support unit for supporting a follow-up session for an individual implantable medical device (IMD).
  • IMD implantable medical device
  • the processor is adapted to:
  • the follow up support unit is able to automatically generate useful information about irregularities that are not available to any device that only is considering information received from an individual IMD.
  • the irregularity index can be a composed variable or a one or more digit number.
  • individual irregularity indices would be create for different therapies or IMD setups in order to compare these setups with each other.
  • ATP antitachycardia therapy
  • the data processor is further adapted to calculate a list of hints upon generating said indication, wherein said list of hints is calculated on the basis of said irregularity messages stored in said data base and wherein said list of hints comprises at least one of:
  • Such suggestions can help the physician during a follow up session.
  • the telemetry link may either be a direct link as is provided by a programmer directly communicating with an IMD or an indirect link via a remote service center.
  • the IMD follow-up support unit is adapted to generate display messages that include a hint generated and may include response buttons that allow a user to respond to said hints.
  • the follow-up system can further be adapted to process a response and to eventually initiate reprogramming of the IMD according to the hint, if possible.
  • the response buttons can be actuated by means of e.g. a computer mouse.
  • the display may be touch sensitive allowing direct actuation of the buttons displayed.
  • Another alternative would be means for voice control of the IMD follow-up unit to respond to the messages displayed.
  • the follow-up support system is adapted to gives the physician conducting the follow-up the possibility
  • the follow-up support unit is adapted to group and priorize the irregularities according to an internally stored irregularity priority list and to initiate displaying of the irregularities highest priority first.
  • a further aspect of the invention relates to a work station (e.g., the programmer itself) comprising a follow up support unit as disclosed herein before.
  • the follow-up support unit can be part of a remote service center that can be linked to an external device for communicating with an IMD.
  • the external device preferably is a workstation that is adapted for wireless data communication with the IMD.
  • the problem if solved by a method of generating support hints assisting in a follow-up session for an implantable medical device, said method comprising:
  • said hints comprise
  • the method preferably includes:
  • the method may include grouping and priorizing the irregularities according to a stored irregularity priority list and presenting the irregularities highest priority first.
  • FIG 1 a system comprising an implantable medical device 10, an external device 2 and a remote service center 4 are shown.
  • the implantable medical device 10 is an implantable heart stimulator that can act as a biventricular pacemaker and cardioverter/defibrillator.
  • the heart stimulator 10 comprises a telemetry unit 82 for wireless data communication with the external device.
  • the external device can wirelessly communicate with the heart stimulator 10 and thus can act as a programmer for the heart stimulator.
  • the external device 2 provides for a link to the remote service center 4 to upload data to the service center 4 and to download data from the service center 4.
  • the external device 2 reads out data from the heart stimulator 10 and uploads the data to the service center.
  • the external device 2 is a work station.
  • the service center collects data received from different external devices belonging to different heart stimulators.
  • the service center processes these data in order to calculate irregularity indices.
  • the data uploaded to the service center IMD includes an identification code identifying an individual IMD and an IMD type, and IMD irregularity messages including data identifying type and date of an irregularity.
  • the service center calculates both, a device specific irregularity index and
  • stimulator 10 comprises a case 12 and header 14.
  • the heart stimulator 10 is connected to three electrode leads, namely a right ventricular electrode lead for 16, a right atrial electrode lead 18 and a left ventricular electrode lead 20.
  • the left ventricular electrode lead 20 is designed to pass trough the coronary sinus of heart 22.
  • Left ventricular electrode lead 20 comprises a left ventricular tip electrode 24 at the distal end a left ventricular electrode lead 20 and a left ventricular ring electrode 26.
  • Atrial electrode lead 18 comprises a right atrial tip electrode 28 at the distal end of right atrial electrode lead 18 and a right atrial ring electrode 30.
  • the right ventricular electrode lead 16 comprises right ventricular tip electrode 32 at the distal end of right ventricular electrode lead 16 and a right ventricular ring electrode 34.
  • heart stimulator 10 may be adapted to act as an implantable cardioverter/defibrillator (ICD)
  • ventricular electrode lead 16 also exhibits a ventricular shock coil 36 for the delivery of defibrillation shocks to right ventricle 38 of heart 22 and an atrial shock coil 40 for the delivery of atrial defibrillation shocks to a right atrium 42 of heart 22.
  • ICD implantable cardioverter/defibrillator
  • Each electrode and shock coil of electrode leads 16 to 20 is separately connected to an electric circuit enclosed by case 12 of heart stimulator 10 by way of electrical contacts of a plaque (not shown) at the proximal end of each electrode lead 16 to 20 and corresponding contacts (not shown) in header 14 of heart stimulator 10.
  • Right atrial shock coil 40 is connected to right atrial shock generator 50 (see figure 2 ) that is controlled by a control unit 52 of heart stimulator 10.
  • right ventricular shock coil 36 is connected to a right ventricular shock generator 54 that is also connected to control unit 52.
  • Right atrial tip electrode 28 and right atrial ring electrode 30 are both connected to a right atrial stimulation pulse generator 56 and a right atrial sensing stage 58 that internal both connected to control unit 52.
  • Sensing stages are provided in order to be able to sense a contraction a heart chamber that naturally occurs without artificial stimulation and that is called intrinsic.
  • An intrinsic excitation of a heart chamber results in characteristic electrical potentials that can be picked up via the sensing electrode and that can be evaluated by the sensing stage in order to determine whether an intrinsic excitation - called: intrinsic event - has occurred.
  • Separate sensing stages 58, 62 and 66 are provided for the right atrium RA 42, right ventricle RV 38 and left ventricle LV 70.
  • the pacemaker By means of a sensing stage for a heart chamber to be stimulated, the pacemaker is able to only trigger stimulation pulses when needed that is when no intrinsic excitation of the heart chamber occurs in time.
  • Such mode of pacing a heart chamber is called demand mode.
  • the pacemaker schedules an atrial or a ventricular escape interval that causes triggering of an atrial or ventricular stimulation pulse when the escape interval times out. Otherwise, if an intrinsic atrial or ventricular event is detected prior to time out of the respective atrial or ventricular escape interval, triggering of the atrial or ventricular stimulation pulse is inhibited.
  • Such intrinsic (natural, non-stimulated) excitation are manifested by the occurrence of recognizable electrical signals that accompany the depolarization or excitation of a cardiac muscle tissue (myocardium).
  • the depolarization of the myocardium is usually immediately followed by a cardiac contraction.
  • depolarization and contraction may be considered as simultaneous events and the terms "depolarization” and “contraction” are used herein as synonyms.
  • Right atrial stimulation pulse generator 56 is adapted to generate atrial stimulation pulses of sufficient strength to cause an excitation of atrial myocardium by an electrical stimulation pulse delivered via right atrial tip electrode 28 and right atrial ring electrode 30.
  • means are provided to adapt the right atrial stimulation pulse strength to the stimulation threshold.
  • Right atrial sensing stage 58 is adapted to pick up myocard cardial potentials indicating an intrinsic atrial excitation that corresponds to a natural atrial contraction. By way of right atrial sensing stage 58, it is possible to stimulate the right atrium 42 of heart 22 in a demand mode wherein a right atrial stimulation pulse is inhibited if an intrinsic atrial event (intrinsic atrial excitation) is sensed by right atrial sensing stage 58 prior to expiration of an atrial escape interval.
  • an intrinsic atrial event intrinsic atrial excitation
  • right ventricular ring electrode 34 and right ventricular tip electrode 32 are connected to right ventricular stimulation pulse generator 60 and to a right ventricular sensing stage 62 that in turn are connected to control unit 52.
  • right ventricular tip electrode 32, right ventricular ring electrode 34, right ventricular stimulation generator 60 and right ventricular sensing stage 62 right ventricular stimulation pulses can be delivered in a demand mode to the right ventricle 38 of heart 22.
  • left ventricular tip electrode 32 and left ventricular ring electrode 26 are connected to the left ventricular stimulation pulse generator 64 and the left ventricular sensing stage 66 that internal connected to control unit 52 and that allow for stimulating a left ventricle 70 of heart 22.
  • Triggering and inhibition of delivery of stimulation pulses to the right atrium, the right ventricle or the left ventricle is controlled by control unit 52 in a manner generally known to the man skilled in the art.
  • the timing that schedules delivery of stimulation pulses if needed is controlled by a number of intervals, that at least partly may depend on a hemodynamic demand of a patient that is sensed by means of an activity sensor 72 that is connected to control unit 52.
  • Activity sensor 72 allows for rate adaptive pacing wherein a pacing rate (the rate of consecutive ventricular stimulation pulses for a duration of consecutive atrial stimulation pulses) depends on a physiological demand of a patient that is sensed by a way of activity sensor 72. Details of rate adaptation are known to the man skilled in the art but need not to be explained in detail in this description.
  • an actual stimulation rate determines the timing from one (paced) heart cycle to another
  • intervals like an atrioventricular delay interval and an interventricular delay interval determine the timing within one heart cycle.
  • the right ventricle would be excited (either intrinsically or paced) at the end of an atrioventricular delay interval.
  • a left ventricular contraction should follow the right ventricular contraction at the end of an interventricular delay interval. This shall include the case, wherein the right ventricle and the left ventricle are excited the same time resulting in an interventricular delay interval duration of zero. Also, it is possible that the left ventricle is excited prior to the right ventricle resulting in an negative interventricular delay interval duration.
  • the atrioventricular delay interval duration and the interventricular delay interval duration need to be adapted to an individual heart in order to achieve an optimized cardiac output.
  • Adaptation of these and other parameters is performed during implantation and during follow-up sessions taking into account irregularities that may have occurred since implantation or a previous follow-up session.
  • either the external device 2 or the remote service center is adapted to allow the following scenario:
  • the external device 2 or the service center 4 gives the physician conducting the follow-up the possibility
  • the external device 2 or the service center 4 may give the physician conducting the follow-up the possibility to automatically re-program the implant as suggested.
  • the external device 2 or the service center 4 groups and priorizes the irregularities according to an internally stored irregularity priority list and presents the irregularities highest priority first.
  • follow-up support unit is accessible over any internet-connected computer and for every physician who has the right to view and change the patient's data.
  • Figure 4 shows a workstation 2 that is used as the external device of figure 1 .
  • Workstation 2 comprises a touch sensitive display 90 that allows displaying of the hints generated and of response buttons 92 that can be actuated by a physician.
  • Reprogram device Suggestion Ok - Change course of therapy? Exchange all programmed ramps into bursts. Many VT1 Not of interest 38 ventricular tachycardia (VT1) detected since last follow-up. This is above average (average for this implant type within the same time: 4). Reprogram device Suggestion: Ok - Examine IEGMs for T-wave oversensing - Examine patient medication - Change programmed VT1 zone (currently: 120 bpm) to 140 bpm.
  • CHF worsened Not of interest The CHF index for this patient changed from 1.3 to 4.5 (on a scale from 1..10). This is above average (average increase for this implant type within the same time: 0.3).
EP08075255.3A 2007-04-30 2008-03-31 Système de support de suivi pour dispositifs médicaux implantables Not-in-force EP1987858B1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US11/742,349 US20080269569A1 (en) 2007-04-30 2007-04-30 Follow-up support system for implantable medical devices

Publications (3)

Publication Number Publication Date
EP1987858A2 true EP1987858A2 (fr) 2008-11-05
EP1987858A3 EP1987858A3 (fr) 2009-09-16
EP1987858B1 EP1987858B1 (fr) 2016-08-03

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EP08075255.3A Not-in-force EP1987858B1 (fr) 2007-04-30 2008-03-31 Système de support de suivi pour dispositifs médicaux implantables

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EP (1) EP1987858B1 (fr)

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TW201108144A (en) * 2009-08-19 2011-03-01 Aescu Technology Remote healthcare method for measuring physiological parameter and reporting self-perceived health status
US9744364B2 (en) * 2013-09-25 2017-08-29 Medtronic, Inc. Method and apparatus for automatic configuration of implantable medical devices

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US20030028082A1 (en) 2001-07-31 2003-02-06 Medtronic, Inc. Method and system of follow-up support for a medical device

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US5476483A (en) * 1994-06-10 1995-12-19 Pacesetter, Inc. System and method for modulating the base rate during sleep for a rate-responsive cardiac pacemaker
FR2744817B1 (fr) * 1996-02-08 1998-04-03 Ela Medical Sa Dispositif medical implantable actif et son programmateur externe a mise a jour automatique du logiciel
US6024699A (en) * 1998-03-13 2000-02-15 Healthware Corporation Systems, methods and computer program products for monitoring, diagnosing and treating medical conditions of remotely located patients
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US20030028082A1 (en) 2001-07-31 2003-02-06 Medtronic, Inc. Method and system of follow-up support for a medical device

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Publication number Publication date
EP1987858A3 (fr) 2009-09-16
EP1987858B1 (fr) 2016-08-03
US20080269569A1 (en) 2008-10-30

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